NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2024-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs

NCT05826223

Sepsis

RECRUITING

Next-Generation Sequencing Diagnostics of Bacteremia in Sepsis

NCT03356249

Sepsis Septic Shock

COMPLETED

Pulse Photoplethysmography as an Early Tool for the Diagnosis of Sepsis

NCT04149132

Sepsis

COMPLETED

New Strategy to Predict Early Sepsis

NCT04118179

Sepsis

UNKNOWN

Hemospec Device for the Diagnosis of Sepsis

NCT03306186

Sepsis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Early start of antimicrobials is the cornerstone of management of critically ill patients. The appropriate time window for this early intervention may vary greatly, but it is considered to be one to 3 hours from hospital admission. However, the choice of the antimicrobials for early intervention relies on empirical selection and may several times be inappropriate due to the emergence of antimicrobial resistance. The only way to overcome this difficulty is guidance through early microbial identification and antibiotic susceptibility testing (AST). However, blood cultures are positive in almost 20% of critically ill patients and AST may delay as much as 72 hours.

This means that another type of approach is warranted which will tackle the major limitation of standard-of-care (SoC) microbiology, namely, the need to incubate whole blood into flasks enriched with growth media which necessitates subculturing once a blood flask turns positive. It is evident that rapid identification of the pathogen followed by AST using whole blood without the need of blood culture can be a major advance in the diagnostic field.

The present study is based on previous analysis of ethylenediaminetetraacetic acid (EDTA) whole blood coming from patients with known bloodstream infection. Next generation sequencing (NGS) of bacterial DNA extracted from whole blood managed to identify the correct pathogen. This study is aiming at the validation of this NGS -based assay in a broader number of patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia Acute Pyelonephritis Bacteremia Biliary Tract Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with an infection

Patients with high suspicion of infection with at least one sign of the quick Sequential Organ Failure Assessment (qSOFA) score

NGS-based assay for bacterial identification

Intervention Type DIAGNOSTIC_TEST

A total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NGS-based assay for bacterial identification

A total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age equal to or above 18 years.
* Both genders.
* Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
* Patients with high suspicion of infection with at least one sign of the quick SOFA score (i.e. one of mental confusion, more than 22 breaths per minute or systolic blood pressure less than 100mmHg).